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NIHR Signal Oral steroids do not help hearing for children with glue ear

Oral steroids do not improve hearing, symptoms, or quality of life in children with glue ear. This NIHR-funded trial compared oral steroids with placebo for 389 children with glue ear, also called otitis media with effusion, and found no significant effect on those outcomes.

Glue ear is when the middle ear fills with fluid, often following an ear or respiratory infection. The fluid makes hearing more difficult. It usually resolves within three months without treatment, but if it lasts longer, the hearing loss may cause delayed language development or difficulties with communicating, for instance at school.

This study shows that many children will improve spontaneously, even after three months of glue ear and confirms that steroids are not useful, even though they are well tolerated. Surgery to place ventilation tubes known as grommets is an option for children with persistent glue ear in and hearing loss in both ears. This evidence supports more informed discussions with parents about watchful waiting and the surgical options available.

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Why was this study needed?

Otitis media with effusion, glue ear, is a common problem in childhood that can need an operation. It would be very useful to families and the NHS if a drug could help children to improve without needing surgery.

A 2011 Cochrane review looked at steroids taken orally or by nasal spray for treating glue ear. Nasal steroids did not improve glue ear or hearing loss. Oral steroids with or without antibiotics reduced symptoms of glue ear one month after treatment but had no long-term effects or any effects on hearing loss. No other drug treatments are known to be effective for improving the condition.

Most previously identified studies were small and of poor quality. So this trial aimed to recruit a large number of children and to see if a well-designed trial could resolve the question of whether oral steroids could improve hearing outcomes for children who have lived with glue ear for at least three months and have documented hearing loss.

What did this study do?

The OSTRICH randomised controlled trial was conducted in 20 outpatient departments treating ear, nose and throat disorders in England and Wales. In all, 389 children aged two to eight with glue ear for three months and hearing loss participated. Two hundred were assigned to the soluble oral steroid prednisolone daily for seven days and 189 children were assigned to placebo. The dose of prednisolone was 20 mg daily for children aged two to five years and 30 mg daily for children aged six to eight years.

Randomisation was balanced by the age of the child and by trial site. Parents, children, clinicians and researchers were blinded to treatment allocation and this was a well-conducted trial, thus minimising bias.

What did it find?

Overall, 40% (73/183) of children taking oral steroids and 33% (459/180) taking placebo had acceptable hearing four weeks after treatment. This represents an absolute difference of 7 percentage points that is statistically non-significant (95% confidence interval [CI] –3 to 17) and below the 15% difference that researchers thought would be clinically important. Acceptable hearing was defined as less than or equal to 20 or 25 decibels Hearing Level (db HL) depending on the type of measurement used.

Similar non-significant results were seen at 12 months, with 69% (118/170) children who had taken steroids having acceptable hearing compared to 61% (99/162) who took a placebo.

After 12 months, the mean otitis media symptom score measured by OM8-30 was −0.22 in children taking steroids and – 0.29 in children taking a placebo (adjusted difference 0.05, 95% CI −0.12 to 0.22). Lower scores mean a better quality of life related to otitis media according to infection-related physical health, general developmental impact and hearing difficulties.

What does current guidance say on this issue?

NICE’s 2008 guideline on otitis media with effusion in under 12s covers management of children who have glue ear in both ears and persistent hearing loss. It recommends against the use of topical or oral steroids for managing otitis media with effusion.

Surgical intervention with ventilation tubes, called grommets, is recommended for children who are affected for at least three months and have a hearing level of 25 to 30 dB HL in the better ear.

What are the implications?

The findings confirm the high rate of spontaneous resolution of glue ear at six months and one year. The small seven percentage point increase in acceptable hearing at five weeks was not statistically significant or clinically important and suggests that steroids do not have a worthwhile effect on hearing. Quality of life did not differ between groups, and this supports current guidance that oral steroids should not be prescribed for glue ear in children.

Grommets remain an option for those with bilateral effusion and persistent hearing loss.

There is a need to continue the search for effective non-invasive treatments for glue ear in children.

Why was this study needed?

Otitis media with effusion, glue ear, is a common problem in childhood that can need an operation. It would be very useful to families and the NHS if a drug could help children to improve without needing surgery.

A 2011 Cochrane review looked at steroids taken orally or by nasal spray for treating glue ear. Nasal steroids did not improve glue ear or hearing loss. Oral steroids with or without antibiotics reduced symptoms of glue ear one month after treatment but had no long-term effects or any effects on hearing loss. No other drug treatments are known to be effective for improving the condition.

Most previously identified studies were small and of poor quality. So this trial aimed to recruit a large number of children and to see if a well-designed trial could resolve the question of whether oral steroids could improve hearing outcomes for children who have lived with glue ear for at least three months and have documented hearing loss.

What did this study do?

The OSTRICH randomised controlled trial was conducted in 20 outpatient departments treating ear, nose and throat disorders in England and Wales. In all, 389 children aged two to eight with glue ear for three months and hearing loss participated. Two hundred were assigned to the soluble oral steroid prednisolone daily for seven days and 189 children were assigned to placebo. The dose of prednisolone was 20 mg daily for children aged two to five years and 30 mg daily for children aged six to eight years.

Randomisation was balanced by the age of the child and by trial site. Parents, children, clinicians and researchers were blinded to treatment allocation and this was a well-conducted trial, thus minimising bias.

What did it find?

Overall, 40% (73/183) of children taking oral steroids and 33% (459/180) taking placebo had acceptable hearing four weeks after treatment. This represents an absolute difference of 7 percentage points that is statistically non-significant (95% confidence interval [CI] –3 to 17) and below the 15% difference that researchers thought would be clinically important. Acceptable hearing was defined as less than or equal to 20 or 25 decibels Hearing Level (db HL) depending on the type of measurement used.

Similar non-significant results were seen at 12 months, with 69% (118/170) children who had taken steroids having acceptable hearing compared to 61% (99/162) who took a placebo.

After 12 months, the mean otitis media symptom score measured by OM8-30 was −0.22 in children taking steroids and – 0.29 in children taking a placebo (adjusted difference 0.05, 95% CI −0.12 to 0.22). Lower scores mean a better quality of life related to otitis media according to infection-related physical health, general developmental impact and hearing difficulties.

What does current guidance say on this issue?

NICE’s 2008 guideline on otitis media with effusion in under 12s covers management of children who have glue ear in both ears and persistent hearing loss. It recommends against the use of topical or oral steroids for managing otitis media with effusion.

Surgical intervention with ventilation tubes, called grommets, is recommended for children who are affected for at least three months and have a hearing level of 25 to 30 dB HL in the better ear.

What are the implications?

The findings confirm the high rate of spontaneous resolution of glue ear at six months and one year. The small seven percentage point increase in acceptable hearing at five weeks was not statistically significant or clinically important and suggests that steroids do not have a worthwhile effect on hearing. Quality of life did not differ between groups, and this supports current guidance that oral steroids should not be prescribed for glue ear in children.

Grommets remain an option for those with bilateral effusion and persistent hearing loss.

There is a need to continue the search for effective non-invasive treatments for glue ear in children.

BACKGROUND: Children with persistent hearing loss due to otitis media with effusion are commonly managed by surgical intervention.
A safe, cheap, and effective medical treatment would enhance treatment options. Underpowered, poor-quality trials have found short-term benefit from oral steroids. We aimed to investigate whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss.
METHODS: In this individually randomised, parallel, double-blinded, placebo-controlled trial we recruited children aged 2-8 years with symptoms attributable to otitis media with effusion for at least 3 months and with confirmed bilateral hearing loss. Participants were recruited from 20 ear, nose, and throat (ENT), paediatric audiology, and audiovestibular medicine outpatient departments in England and Wales. Participants were randomly allocated (1:1) to sequentially numbered identical prednisolone (oral steroid) or placebo packs by use of computer-generated random permuted block sizes stratified by site and child's age. The primary outcome was audiometry-confirmed acceptable hearing at 5 weeks. All analyses were by intention to treat. This trial is registered with the ISRCTN Registry, number ISRCTN49798431.
FINDINGS: Between March 20, 2014, and April 5, 2016, 1018 children were screened, of whom 389 were randomised. 200 were assigned to receive oral steroids and 189 to receive placebo. Hearing at 5 weeks was assessed in 183 children in the oral steroid group and in 180 in the placebo group. Acceptable hearing was observed in 73 (40%) children in the oral steroid group and in 59 (33%) in the placebo group (absolute difference 7% [95% CI -3 to 17], number needed to treat 14; adjusted odds ratio 1.36 [95% CI 0.88-2.11]; p=0.16). There was no evidence of any significant differences in adverse events or quality-of-life measures between the groups.
INTERPRETATION: Otitis media with effusion in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution.
A short course of oral prednisolone is not an effective treatment for most children aged 2-8 years with persistent otitis media with effusion, but is well tolerated. One in 14 children might achieve improved hearing but not quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence.
FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment programme.

Decibels Hearing Level (db HL) is a measure of hearing relative to the quietest sounds that a young healthy individual can hear (0 decibels). It shows how loud a sound has to be for a person to hear it. A decibels Hearing Level of 20 – 40 represents mild hearing loss.

Expert commentary

Despite glue ear being the commonest cause of hearing loss in young children, we don't have strong evidence to tell us how best to manage it.

Several factors are thought to be important in the development and persistence of glue ear in childhood. As such, it is not surprising that this well designed and conducted placebo-controlled trial did not demonstrate sufficient benefit to change current practice. However, this study represents another piece in the jigsaw puzzle of how best to manage childhood glue ear.

The authors very reasonably conclude that studies to better understand how to reduce the impact of hearing loss on childhood development might be more helpful than trying to find new treatments for childhood glue ear.

Professor I A Bruce, Consultant Paediatric Otolaryngologist, Royal Manchester Children's Hospital; Honorary Clinical Professor of Paediatric Otolaryngology, University of Manchester